Swiss Cardiac Amyloidosis REgistry (Swiss-CARE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Amyloid Cardiomyopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Cardiac transthyretin amyloidosis (ATTR), caused by ventricular depositions of misfolded transthyretin, results in an infiltrative cardiomyopathy, progressing from pronounced myocardial wall thickening, diastolic and systolic dysfunction to the development of terminal heart failure. Recently, treatment options for TTR amyloidosis have become available. However costs for therapy are enormous and previous trials were not able to differentiate between patients that might benefit from treatment and those without a need for treatment. the investigators study aims to determine markers, as assessed by cardiac magnet resonance imaging (CMR) feature tracking (FT) and T1- and T2- mapping, that might reliably indicate disease severity and could help to identify patients that might benefit from (ongoing) TTR stabilization treatment.
Detailed description
Cardiac transthyretin amyloidosis (ATTR), the most common amyloidosis form with cardiac involvement, is caused by tissue deposition of misfolded TTR, a transport Protein for thyroxine and retinol. Ventricular depositions of amyloid fibrils results in an infiltrative cardiomyopathy, progressing from pronounced myocardial wall thickening, to diastolic and systolic dysfunction and finally chronic heart failure.
While treatment options are now available, it remains unclear how to monitor therapy response and disease progression. No makers have been identified that predict outcome prior to initiation of therapy, thus patient selection for therapy remains challenging.
The investigators study will address these issues and will provide systematically assessed CMR data before and over the course of 18 months after therapy initiation. Clinical and laboratory follow-up will be performed every 3-6 months. The investigators study is based on an open, uncontrolled, structured collection of retrospective and prospective data from all patients diagnosed with amyloidosis at the Inselspital Bern with the aim to follow patients undergoing therapy.
The investigators hypothesize that CMR feature tracking (FT) and measures of T1- and T2- mapping, such as extracellular volume (ECV) may better correlate with disease severity and help to identify patients likely to benefit from (ongoing) TTR stabilizing therapy. Beside standard CMR assessments, the investigators will use CMR feature tracking to quantify global and regional myocardial function. FT has proven to be an excellent predictor in various cardiomyopathies.
The proposed study will evaluate the potential of CMR to identify patients likely to benefit from therapy, monitor treatment response and balance individual patient benefit and health care cost.
Primary outcome measures
- LV (left ventricle) and RV (right ventricle) function as assessed by CMR feature tracking as predictor for MACE (major adverse cardiac event) [Time frame: 5 years]
- LV and RV tissue characterization as assessed by T1 and T2 mapping as predictor for MACE [Time frame: 5 years]
- Late gadolinium enhancement as predictor for MACE [Time frame: 5 years]
- Extracellular volume (ECV) as predictor for MACE [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Confirmed diagnosis of amyloidosis w/wo cardiac involvement
- General Consent
Exclusion criteria
- Inability to give consent or existence of a written or documented oral refusal of the data subject.<18 years of age
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Switzerland · 7 centers
- USB — Basel
- Department of Cardiology, University Hospital Bern, Inselspital, Bern — Bern
- HUG — Geneva
- CHUV — Lausanne
- LUKS — Lucerne
- KSSG — Sankt Gallen
- Stadtspital Triemli — Zurich
Publications
- Dobner S, Tawo S, Noti F, Wieser F, Grani C, Nitsche C, Reichlin T, Hunziker L, Haeberlin A. Indication and electrical performance of conventional, resynchronization, and conduction system pacing in transthyretin amyloid cardiomyopathy. Heart Rhythm O2. 2026 Mar 27;7(7):1289-1301. doi: 10.1016/j.hroo.2026.03.026. eCollection 2026 Jul. PMID 42488169
- Caobelli F, Popescu CE, Gozlugol N, Rominger A, Zangeneh FA, Munsch LH, Ciocca N, Stortecky S, Dobner S, Hundertmark M, Grani C. Correlation of global and regional quantitative 99m Tc-3,3-diphosphono-1,2 propanodicarboxylicacid single-photon emission computed tomography with echocardiography in patients with suspected transthyretin-related cardiomyopathy. Nucl Med Commun. 2026 Jun 1;47(6):638-643. PMID 41804669
- Caobelli F, Gozlugol N, Bakula A, Rominger A, Schepers R, Stortecky S, Hunziker Munsch L, Dobner S, Grani C. Prognostic Value of [99mTc]Tc-DPD Quantitative SPECT/CT in Patients with Suspected and Confirmed Amyloid Transthyretin-Related Cardiomyopathy and Preserved Left Ventricular Function. J Nucl Med. 2024 Jun 3;65(6):944-951. doi: 10.2967/jnumed.123.266926. PMID 38724281
Identifiers
NCT: NCT04776824 · 2021-00135